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A Study of MK-8189 in Participants With Schizophrenia (MK-8189-014)
Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The main inclusion
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 17 days
Summary
This trial is testing a new medication called MK-8189 in people with schizophrenia. The goal is to see if different doses are safe and can be tolerated well by patients. This could help find a new treatment option for managing schizophrenia.
Eligible Conditions
- Schizophrenia
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 17 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 17 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Experiencing an Adverse Event (AE)
Number of Participants Who Discontinue From Study Treatment Due to an AE
Side effects data
From 2018 Phase 2 trial • 224 Patients • NCT0305533818%
Weight increased
13%
Sedation
11%
Headache
9%
Dizziness
9%
Akathisia
9%
Nausea
7%
Fatigue
7%
Dyspepsia
7%
Lethargy
7%
Agitation
4%
Schizophrenia
4%
Somnolence
2%
Decreased appetite
2%
Vomiting
2%
Anxiety
2%
Alcohol poisoning
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risperidone
MK-8189
Placebo
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: MK-8189 Panel CExperimental Treatment1 Intervention
Participants will receive MK-8189 48 mg on Days 1-2 and 80 mg on Day 3 based on safety and tolerability.
Group II: MK-8189 Panel A-1Experimental Treatment1 Intervention
Participants will receive MK-8189 48 mg on Day 1 and 80 mg on Day 2.
Group III: MK-8189 Panel AExperimental Treatment1 Intervention
Participants will receive MK-8189 starting at 48 mg on Day 1 and 60 mg on Day 2.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive MK-8189-matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-8189
2020
Completed Phase 2
~1180
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
4,032 Previous Clinical Trials
5,189,663 Total Patients Enrolled
23 Trials studying Schizophrenia
2,633 Patients Enrolled for Schizophrenia
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,905 Previous Clinical Trials
8,091,436 Total Patients Enrolled
28 Trials studying Schizophrenia
4,573 Patients Enrolled for Schizophrenia